The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Device Description

The Mammotome Biopsy System is a mechanical breast biopsy device used in incisional breast biopsy. The Mammotome Biopsy System may be used with imaging guidance (stereotactic or ultrasound).
The Mammotome Biopsy System consists of three major components: a disposable trocar tipped needle-like probe, a reusable holster/cable assembly into which the probes are loaded, and a remote, reusable control module. The system uses vacuum assistance to gather tissue samples and a high-speed rotating cutter. The procedure is referred to as "directional vacuum-assisted biopsy."

AI/ML Overview

The provided text describes the Mammotome Biopsy System and its substantial equivalence to predicate devices, focusing on an updated "Indications for Use." However, it does not contain the detailed acceptance criteria or results of a study designed to prove the device meets specific performance criteria in the format requested.

The document is a 510(k) summary from 2003, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against specific acceptance criteria for a new device.

While it mentions "Clinical data from a multicenter study are provided that supports the additional Indications for use," it does not elaborate on:

Specific acceptance criteria: What quantitative or qualitative metrics defined success for the new indications?
Reported device performance: What were the results of the multicenter study in relation to these criteria?
Sample size and data provenance: How many patients were in the study? Where did the data come from? Was it retrospective or prospective?
Expert details or ground truth establishment: How was the ground truth (e.g., confirmed diagnosis) established for the study cases?
Adjudication method, MRMC studies, or standalone performance: These specific details about study design are not present.
Training set details: Since this is a biopsy device and not AI software, the concept of a "training set" in the context of machine learning doesn't apply directly.

Therefore, I cannot populate the table or answer most of your specific questions based on the provided text.

The document primarily states:

Device: Mammotome Biopsy System
Predicate Device: Mammotome Biopsy System (K992813) and Mammotome Hand Held System (K991980)
Change: Only the Indications for Use was changed.
Evidence for change: "Clinical data from a multicenter study are provided that supports the additional Indications for use."
Conclusion: The FDA determined the device is substantially equivalent for the specified indications for use.

Without the actual study report or further documentation, it's impossible to extract the precise information you've requested regarding acceptance criteria and performance data.

Summary

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030472 1/2

OCT - 9 2003

Mammotome Biopsy System 510(k) Summary of Safety and Effectiveness Information

Company	Ethicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, OH 45242
Contact	Georgia C. Abernathy, MBA, RACSenior Regulatory Affairs AssociateTelephone: (513) 337-3179Fax: (513) 337-1444Email: gabernat@eesus.jnj.com
Date Prepared	October 3, 2003
Device Name	Trade Name: Mammotome Biopsy SystemClassification Name: Biopsy Instrument

Predicate Device Mammotome Biopsy System cleared under K992813 on 11/18/99 and Mammotome Hand Held System cleared under K991980 on 8/17/99.

Device Description

The Mammotome Biopsy System is a mechanical breast biopsy device used in incisional breast biopsy. The Mammotome Biopsy System may be used with imaging guidance (stereotactic or ultrasound).

The Mammotome Biopsy System consists of three major components: a disposable trocar tipped needle-like probe, a reusable holster/cable assembly into which the probes are loaded, and a remote, reusable control module. The system uses vacuum assistance to gather tissue samples and a high-speed rotating cutter. The procedure is referred to as "directional vacuum-assisted biopsy."

Indications for Use

The Mammotome Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

· The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
· The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial removal of palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically

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K030472 2/2

benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Comparison of Technological Characteristics

The proposed and currently marketed devices are identical. No changes were made to design, manufacturing or materials. Only the Indications for Use was changed.

Performance Data

Clinical data from a multicenter study are provided that supports the additional Indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

OCT - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Georgia C. Abernathy, MBA, RAC Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K030472 Trade/Device Name: Mammotome Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: September 9, 2003 Received: September 10, 2003

Dear Ms. Abernathy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing ( 1 1 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2 - Ms. Georgia C. Abernathy, MBA, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Colia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510 (k) Number (if known): K030472

Device Name:

Mammotome@ Biopsy System

Indications for Use:

The Mammotome Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

The Mammotome Biopsy System is intended to provide breast tissue for histologic ↓ examination with partial or complete removal of the imaged abnormality.
The Mammotome Biopsy System is intended to provide breast tissue for histologic . examination with partial removal of a palpable abnormality.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriame C. Provost

(Optional Format 3-10-98)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030472

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.